Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

Not Applicable

• Conditions: Weakness
• Interventions: Procedure: Cycle ergometer physiotherapy; Procedure: Conventional physiotherapy

• Registration Number: NCT02478411
• Lead Sponsor: Hospital Son Llatzer

Brief Summary

Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy.

Detailed Description

Cycloergometric treatment is described to improve the functional and motor status of critically ill subjects. However, there are few studies comparing cycloergometric physiotherapy and conventional physiotherapy in intensive care subjects under mechanical ventilation. The most relevant of these studies conducted by Burtin et al showed beneficial effects of cycloergometric treatment. However, the duration of the physiotherapy sessions in this study differed between groups as cycloergometric group received a double daily dose of treatment. It is known that the intensity of physiotherapy also affects the functional and motor status.

For this reason, the investigators designed a randomized controlled study with early cycloergometric or conventional treatment, with the same intensity between groups to analyze objective functional and motor endpoints.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-14
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-23
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Criteria of functional independence before hospital admission (Barthel scale > 70 points).
• Invasive mechanical ventilation < 72 hours.
• Signed informed consent.

Exclusion Criteria

• Neuromuscular disease (peripheric or central neurologic disorder).
• Presumed fatal evolution in 48 hours.
• Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism).
• Admission due to cardiac arrest.
• Pregnancy.
• Thrombopenia less than 50.000.
• Severe agitation.
• Hemodynamic instability with noradrenaline requirements greater than 1 mcg/kg/min.
• Fraction of inspired Oxygen (FiO2) requirements greater that 0.55 and respiratory rate greater than 30 bpm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cycle ergometer physiotherapy	Cycle ergometer physiotherapy	15 minutes of cycle ergometer physiotherapy plus 15 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit
Conventional physiotherapy	Conventional physiotherapy	30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit

Primary Outcome Measures

Name	Time	Method
Walking test distance at six minutes	At hospital discharge, with an expected average of 4 weeks after hospital admission
Basic activities of daily living score (BADL)	At 28 days after hospital discharge, that is an expected average of 8 weeks
Short Form-36 Health Survey (SF-36), physical functioning section	At 28 days after hospital discharge, that is an expected average of 8 weeks

Secondary Outcome Measures

Name	Time	Method
Lung Functional Testing	At the end of hospital stay, with an expected average of 5 weeks
Presence of intensive care acquired paresis (Medical Research Council score < 48 points)	During ICU admission and ICU discharge, with an expected average of 2 weeks
ICU mobilization scale	During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge
Basic activities of daily living score (BADL)	At 7 days and at 6 months after hospital discharge, that is up to 1 year
Isometric quadriceps force (N/kg)	During ICU admission, with an expected average of 2 weeks	Quadriceps strength will be measured with a handheld dynamometer with patients in supine position and 30º of knee flexion.
Walking test distance at six minutes	At 28 days and at 6 months after hospital discharge, that is up to 1 year
Short Form-36 Health Survey (SF-36), physical functioning section	At 7 days and at 6 months after hospital discharge, that is up to 1 year

Trial Locations

Locations (1)

Hospital Son llàtzer; 🇪🇸 Palma de Mallorca, Illes Balears, Spain